# FDA 483 - Mead Johnson & Company, LLC - December 04, 2017

Source: https://www.globalkeysolutions.net/records/483/mead-johnson-company-llc/f3c1932d-731e-4785-b9ab-d75a3fea3ec9

> FDA 483 for Mead Johnson & Company, LLC on December 04, 2017. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mead Johnson & Company, LLC
- Inspection Date: 2017-12-04
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Mead Johnson Nutrition, an infant formula manufacturer in Zeeland, MI, was cited for significant issues during an FDA inspection. Observations included a failure to establish adequate process controls, leading to the presence of Cronobacter sakazakii in critical processing areas. Additionally, the firm was cited for using equipment not designed to withstand its intended environment, specifically noting a history of internal cracks in spray dryers.

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Company: https://www.globalkeysolutions.net/companies/mead-johnson-company-llc/ce8174b8-a793-423e-a864-edaf39f12a80

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0